MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS25

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2016

Event Type  malfunction  

Event Description

Blood leaked from in line blood gas monitor.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS25
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• MDR Report Key: 5580408
• MDR Text Key: 42805305
• Report Number: 5580408
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS